MKS Instruments to Acquire Atotech

  • $5.1 billion cash and stock transaction combines capabilities in lasers, optics, motion and process chemistry to enable next-generation advanced electronics

  • Accelerates interconnect solutions for customers to address increasing miniaturization demands that enables integration of chips to devices

  • Recurring consumables portfolio for leading edge devices

  • $50 million in annualized cost synergies expected within 18 to 36 months

  • Transaction expected to be accretive to Non-GAAP net earnings per share within the first year

ANDOVER, Mass. and BERLIN, July 01, 2021 (GLOBE NEWSWIRE) — MKS Instruments, Inc. (NASDAQ: MKSI) (“MKS”), a global provider of technologies that enable advanced processes and improve productivity, and Atotech Limited (NYSE: ATC) (”Atotech”), a leading process chemicals technology company and a market leader in advanced electroplating solutions, today announced that they have entered into a definitive agreement pursuant to which MKS will acquire Atotech for $16.20 in cash and 0.0552 of a share of MKS common stock for each Atotech common share. The equity value of the transaction is $5.1 billion and the enterprise value of the transaction is approximately $6.5 billion.

The transaction will result in pro forma annual revenue of $3.8 billion1 and is expected to be accretive to MKS’ Non-GAAP net earnings per share within the first year and additive to MKS’ free cash flow.  MKS expects to realize $50 million in annualized cost synergies within 18 to 36 months.

“Together, MKS and Atotech will be uniquely positioned to drive faster, better solutions and innovations for customers in advanced electronics,” said MKS President and CEO John T.C. Lee.   “By combining leading capabilities in lasers, optics, motion and process chemistry, the combined company will optimize the PCB Interconnect, a significant enabling point of next-generation advanced electronics that represents the next frontier for miniaturization and complexity. We anticipate the addition of Atotech will position MKS to enable roadmaps for future generations of advanced electronics devices. The acquisition of Atotech also provides MKS with a recurring revenue stream from a consumables portfolio for leading-edge devices, with meaningful scale and potential on which to build.”

MKS and Atotech have complementary customer solutions in key advanced electronics markets, with MKS’ expertise in via drilling and Atotech in electroplating. PCBs are becoming increasingly complex as miniaturization is creating new challenges where reliability, productivity and peak performance are critical. The roadmap for next generation interconnects continues to accelerate the need for more integrated solutions that enable yield and throughput gains.

“The combination of Atotech’s expertise in electroplating and chemistry and MKS’ strengths in lasers, laser systems, optics and motion will enable innovative and ground-breaking solutions for customers in the areas of materials processing and complex applications. This transaction is an excellent outcome for our shareholders, and we believe it will provide immediate value and the opportunity to benefit from the upside potential of the combined company,” said Geoff Wild, CEO of Atotech.

MKS intends to fund the cash portion of the transaction with a combination of available cash on hand and committed debt financing.  The combined company is expected to have pro forma net cash and investments of approximately $800 million and total debt outstanding of $5.3 billion at closing, with an estimated gross leverage ratio of under 4.0 times and net leverage ratio of under 3.5 times.2  MKS has also obtained a commitment to replace its current $100 million asset-based revolving credit facility with a $500 million revolving credit facility.

The transaction, expected to be implemented by way of a scheme of arrangement of Atotech under the laws of Jersey, has been unanimously approved by the MKS and Atotech boards of directors and is subject to Atotech shareholder approval, approval of the Royal Court of Jersey, regulatory approvals, and other customary closing conditions, and is expected to close by the fourth quarter of 2021. Carlyle and its affiliates (“Carlyle”), owner of 79% of outstanding Atotech common shares, have signed an irrevocable agreement to vote in favor of the transaction. Eighty percent of shares owned by Carlyle will be subject to a 30-day lock-up period post-closing and 60% of shares owned by Carlyle will be subject to a 60-day lock-up period post-closing.

Perella Weinberg Partners is acting as financial advisor and DLA Piper is acting as legal advisor to MKS. WilmerHale is acting as legal advisor to MKS for the financing. J.P. Morgan and Barclays Bank PLC provided committed financing for the transaction and were advised by Paul Hastings. Credit Suisse is acting as financial advisor and Latham and Watkins is acting as legal advisor to Atotech. Carey Olsen is advising MKS and Ogier is advising Atotech as to Jersey law matters.

___________________
1. Consists of revenue for the last twelve months as of March 31, 2021 for (i) MKS, (ii) Atotech, and (iii) Photon Control Inc., the acquisition of which MKS expects to close in the third quarter of 2021.
2. Based on internal MKS estimate of pro forma Adjusted EBITDA FY 2021, assuming the prior closings of the acquisitions of Atotech and Photon Control Inc. Estimate also includes $50 million of pro forma annual run rate cost synergies.

Conference Call Details

MKS will hold a conference call to discuss this announcement on July 1, 2021 at 8:30 a.m. (Eastern Time). To access a live webcast of the conference call and related presentation materials management will refer to during the call, visit MKS’ website at mksinst.com and click on Company – Investor Relations. The webcast and related presentation materials will be listed in the calendar of events. To participate by telephone, please dial (877) 212-6076 for domestic callers and (707) 287-9331 for international callers, provide the operator with Conference ID 1793197, and access the presentation materials on MKS’ website. An archive of the webcast and related presentation materials will be available on MKS’ and Atotech’s websites.

About MKS Instruments

MKS Instruments, Inc. is a global provider of instruments, systems, subsystems and process control solutions that measure, monitor, deliver, analyze, power and control critical parameters of advanced manufacturing processes to improve process performance and productivity for our customers. Our products are derived from our core competencies in pressure measurement and control, flow measurement and control, gas and vapor delivery, gas composition analysis, electronic control technology, reactive gas generation and delivery, power generation and delivery, vacuum technology, lasers, photonics, optics, precision motion control, vibration control and laser-based manufacturing systems solutions. We also provide services relating to the maintenance and repair of our products, installation services and training. Our primary served markets include semiconductor, industrial technologies, life and health sciences, and research and defense. Additional information can be found at www.mksinst.com.

About Atotech

Atotech is a leading specialty chemicals technology company and a market leader in advanced electroplating solutions. Atotech delivers chemistry, equipment, software, and services for innovative technology applications through an integrated systems-and-solutions approach. Atotech solutions are used in a wide variety of end-markets, including smartphones and other consumer electronics, communications infrastructure, and computing, as well as in numerous industrial and consumer applications such as automotive, heavy machinery, and household appliances.

Atotech, headquartered in Berlin, Germany, is a team of 4,000 experts in over 40 countries generating annual revenue of $1.2 billion in 2020. Atotech has manufacturing operations across Europe, the Americas, and Asia. With its well-established innovative strength and industry-leading global TechCenter network, Atotech delivers pioneering solutions combined with unparalleled on-site support for over 9,000 customers worldwide. For more information about Atotech, please visit us at www.atotech.com.

As noted at the time of Atotech’s public offering, Atotech is not a company subject to regulation under the City Code on Takeovers and Mergers (the ”UK Takeover Code”), therefore no dealing disclosures are required to be made under Rule 8 of the UK Takeover Code by shareholders of MKS or Atotech.

Financial Information; Presentation of Combined Information

Except as otherwise indicated, all financial information of MKS has been reported in accordance with U.S. generally accepted accounting principles (“GAAP”) and all financial information of Atotech has been reported in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board.

The combined financial information set forth herein has not been prepared in accordance with Article 11 of Regulation S-X but rather represents a combination of MKS’ results with the results of Atotech and Photon Control Inc., MKS’ acquisition of which is expected to close in the third quarter of 2021. Except as otherwise stated herein, Atotech financial information has not been conformed to the accounting principles (GAAP) and accounting policies followed by MKS. Combined financial information pursuant to Article 11 could differ materially from the combined information presented herein.

Use of Non-GAAP Financial Measures

This press release includes financial measures that are not in accordance with GAAP (“Non-GAAP financial measures”) and financial measures that are not in accordance with IFRS (“Non-IFRS financial measures”). These Non-GAAP financial measures and Non-IFRS financial measures should be viewed in addition to, and not as a substitute for, MKS’ and Atotech’s reported GAAP and IFRS results, and may be different from Non-GAAP financial measures and Non-IFRS financial measures used by other companies. In addition, these Non-GAAP financial measures and Non-IFRS financial measures are not based on any comprehensive set of accounting rules or principles. MKS management believes the presentation of these Non-GAAP financial measures and Non-IFRS financial measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results.

MKS is not providing a quantitative reconciliation of forward-looking Non-GAAP net earnings to GAAP net income or forward-looking Adjusted EBITDA to GAAP net income because it is unable to estimate with reasonable certainty the ultimate timing or amount of certain significant items without unreasonable efforts. For forward-looking Non-GAAP net earnings to GAAP net income, these items include, but are not limited to, acquisition and integration costs, amortization of intangible assets, amortization of the step-up of inventory to fair value, restructuring and other expense, asset impairment, and the income tax effect of these items. For forward-looking Adjusted EBITDA to GAAP net income, these items include, but are not limited to, net interest expense, depreciation expense, acquisition and integration costs, amortization of intangible assets, restructuring and other expense, asset impairment, the income tax effect of these items, and the provision for income taxes. MKS is also not providing a quantitative reconciliation of forward-looking free cash flow to operating cash flow because it is unable to estimate with reasonable certainty the ultimate timing or amount of capital expenditures without unreasonable efforts, in addition to the timing of payments for acquisition and integration costs and restructuring and other expense, among other items, which will affect operating cash flow. All of these items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the relevant period.

Safe Harbor for Forward-Looking Statements

Statements in this press release regarding the proposed transaction between MKS and Atotech (the “transaction”), the expected timetable for completing the transaction, future financial and operating results and metrics for the combined company, including to reflect MKS’ acquisition of Photon Control Inc., which is expected to close in the third quarter of 2021, benefits and synergies of the transaction, future opportunities for the combined company and any other statements about MKS’ or Atotech’s managements’ future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “projects,” “intends,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “forecasts,” “continues” and similar expressions) should also be considered to be forward-looking statements. These statements are only predictions based on current assumptions and expectations. Actual events or results may differ materially from those in the forward-looking statements set forth herein. Among the important factors that could cause actual events to differ materially from those in the forward-looking statements are: the ability of the parties to complete the transaction; the ability of MKS to complete its acquisition of Photon Control Inc., which is expected to close in the third quarter of 2021; the risk that the conditions to the closing of the transaction, including receipt of required regulatory approvals and approval of Atotech shareholders, are not satisfied in a timely manner or at all; the terms of MKS’ existing term loan, the terms and availability of financing for the transaction, the substantial indebtedness the Company expects to incur in connection with the transaction and the need to generate sufficient cash flows to service and repay such debt; litigation relating to the transaction; unexpected costs, charges or expenses resulting from the transaction; the risk that disruption from the transaction materially and adversely affects the respective businesses and operations of MKS and Atotech; restrictions during the pendency of the transaction that impact MKS’ or Atotech’s ability to pursue certain business opportunities or other strategic transactions; the ability of MKS to realize the anticipated synergies, cost savings and other benefits of the transaction, including the risk that the anticipated benefits from the transaction may not be realized within the expected time period or at all; competition from larger or more established companies in the companies’ respective markets; MKS’ ability to successfully grow Atotech’s business; potential adverse reactions or changes to business relationships resulting from the announcement, pendency or completion of the transaction; the ability of MKS to retain and hire key employees; legislative, regulatory and economic developments, including changing conditions affecting the markets in which MKS and Atotech operate, including the fluctuations in capital spending in the semiconductor industry and other advanced manufacturing markets and fluctuations in sales to MKS’ and Atotech’s existing and prospective customers; the challenges, risks and costs involved with integrating the operations of the companies we acquire; the impact of the COVID-19 pandemic and related private and public measures on Atotech’s business; the ability of MKS to anticipate and meet customer demand; manufacturing and sourcing risks, including supply chain disruptions and component shortages; potential fluctuations in quarterly results; dependence on new product development; rapid technological and market change; acquisition strategy; volatility of stock price; international operations; financial risk management; and the other factors described in MKS’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and any subsequent Quarterly Reports on Form 10-Q, and Atotech’s Annual Report on Form 20-F for fiscal year ended December 31, 2020 and any Reports on Form 6-K, each as filed with the U.S. Securities and Exchange Commission (the “SEC”). MKS and Atotech are under no obligation to, and expressly disclaim any obligation to, update or alter these forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Additional Information and Where to Find It

This communication does not constitute a solicitation of any vote or approval. In connection with the proposed transaction, Atotech plans to provide to its shareholders a circular containing information on the anticipated scheme of arrangement vote regarding the proposed transaction (the “Scheme Circular”). Atotech may also file other documents with the SEC regarding the proposed transaction. This document is not a substitute for the Scheme Circular or any other document that may be filed by Atotech with the SEC.

BEFORE MAKING ANY VOTING DECISION, ATOTECH’S SHAREHOLDERS ARE URGED TO READ THE SCHEME CIRCULAR IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY ATOTECH WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTION BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION.

Any vote in respect of resolutions to be proposed at Atotech shareholder meetings to approve the proposed transaction, the scheme of arrangement or related matters, or other responses in relation to the proposed transaction, should be made only on the basis of the information contained in Atotech’s Scheme Circular. Shareholders may obtain a free copy of the Scheme Circular and other documents Atotech files with the SEC (when available) through the website maintained by the SEC at www.sec.gov. Scheme Circular makes available free of charge on its investor relations website at investors.atotech.com copies of materials it files with, or furnishes to, the SEC.

No Offer or Solicitation

This communication is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

The proposed transaction will be implemented solely pursuant to the scheme of arrangement, subject to the terms and conditions of the definitive agreement between MKS and Atotech, dated July 1, 2021, which contains the full terms and conditions of the proposed transaction.

MKS Contacts:  
Investor Relations:  
David Ryzhik  
Vice President, Investor Relations  
Telephone: +1 978.557.5180  
Email: [email protected]   
  
Press Relations:  
Bill Casey  
Senior Director, Marketing Communications  
Telephone: +1 630.995.6384  
Email: [email protected]
  
Tom Davies / Jeremy Fielding  
Kekst CNC   
Emails: [email protected]/ [email protected]   

Atotech Contacts:  

Investor Relations & Communications:

Sarah Spray
Vice President, Global Head of Investor Relations & Communications
+1 803.504.4731
Email: [email protected]

Patrick Ryan (USA) / Ruediger Assion (Germany)
Edelman
Emails: [email protected] / [email protected]



Oyster Point Pharma Announces Preclinical Data Highlighting Potent Activity of OC-01 (varenicline) and OC-02 (simpinicline) Against SARS-CoV-2 Virus and Variants


  • Administration of OC-01 (varenicline) nasal spray to non-human primates was observed to inhibit viral replication in the nose within 24 hours of infectious SARS-CoV-2 challenge with absence of subgenomic RNA at Day 3 and Day 5 post-challenge



  • Varenicline inhibits cellular entry and replication of SARS-CoV-2 and its alpha and beta variants in multiple human cell types


  • Simpinicline inhibits cellular entry and replication of SARS-CoV-2 alpha variant in Calu-3 human cells with additional variants under investigation


  • Oyster Point Pharma collaborates with the Trudeau Institute for in vitro testing of varenicline, the active ingredient in OC-01 nasal spray and simpinicline, the active ingredient in OC-02 nasal spray


  • Oyster Point Pharma plans to present data at the upcoming Analyst Day, scheduled for July 15, 2021

PRINCETON, N.J., July 01, 2021 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced preclinical data in non-human primates and in vitro models evaluating OC-01 (varenicline) nasal spray against SARS-CoV-2 and the alpha and beta variants, the viruses that cause COVID-19 disease. Administration of OC-01 (varenicline) nasal spray, a highly selective nicotinic acetylcholine receptor agonist, protected rhesus macaques against SARS-CoV-2 nasal infection. The results were published on the preprint server bioRxiv (https://biorxiv.org/cgi/content/short/2021.06.29.450426v1).

“We believe this is the first in vivo and in vitro data illustrating a nicotinic acetylcholine receptor agonists’ potential to inhibit viral entry and disrupt replication of the SARS-CoV-2 virus and variants,” said Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point. “We believe that OC-01 (varenicline) nasal spray has the potential to complement the current global vaccination strategy and prevent infection and reduce transmission of the SARS-CoV-2 virus with a mechanism of action that may have broad activity across multiple variants.”

On Day 1, using a viral infection model and following two administrations of 100 µl of OC-01 (varenicline) nasal spray (0.6 mg/ml varenicline) into each nostril, animals were challenged with a very high viral inoculum (approximately 70 thousand plaque-forming units) of active SARS-CoV-2, via both intranasal (nose) and intratracheal (lung) routes. Animals then received two additional administrations of OC-01 (varenicline) nasal spray into each nostril on Day 1, followed by four times daily for the following four days. Administration of OC-01 (varenicline) nasal spray resulted in inhibition of cellular entry and replication of SARS-CoV-2, illustrated by a decrease of detectable SARS-CoV-2 subgenomic RNA (sgRNA) by approximately 2 logs compared to controls with complete absence in all animals at 3 days and 5 days post-challenge. In control animals treated with the same lot of virus inoculum, nasal swabs reached a peak of approximately 10 million SARS-CoV-2 sgRNA copies within two days of viral challenge and were present throughout the course of the study. The absence of sgRNA indicates that the SARS-CoV-2 virus had not significantly infected nasal mucosa cells to start the transcription process of building new infectious virions. The absence of sgRNA following this very high viral inoculum also suggests the possibility of transmission may be substantially reduced after treatment with OC-01 (varenicline) nasal spray.

SARS-CoV-2 has been shown to predominantly enter the human body via nasal epithelial cells1, specifically ciliated and mucous secreting cells of the nasal mucosa2,3. Therefore, the nasal cavity represents a highly susceptible mucosal surface for infection and amplification within the respiratory tree. The nasal cavity also allows for treatment with topical compounds that can be delivered in higher local concentrations with potentially lower systemic exposure that may not be achievable when administered as an oral tablet or IV infusion.

In a separate study, in collaboration with the Trudeau Institute, researchers evaluated the in vitro antiviral activity of varenicline against SARS-CoV-2 and SARS-CoV-2 alpha and beta variants using Calu-3 (human airway epithelial cells) and Caco-2 (colon epithelial cells) cell lines. “Varenicline has demonstrated potent antiviral activity against SARS-CoV-2 and variants, alpha and beta, in cell culture. The promising in vitro and in vivo data suggest a clinical path forward for OC-01, which could prove a potential treatment in preventing severe COVID-19 symptoms and the spread of infection. Further studies investigating the mechanism of action and its effect on other variants of concern, such as the gamma and delta variants are ongoing,” said Priya Luthra, PhD, Trudeau Institute Principal Investigator.

Additionally, OC-02 (simpinicline), a highly selective nicotinic acetylcholine receptor agonist was evaluated for in vitro antiviral activity against the SARS-CoV-2 alpha variant using Calu-3 cell lines. Simpinicline demonstrated potent antiviral activity against the SARS-CoV-2 variants in cell culture with an IC50 of 0.04 µM. Further studies investigating the antiviral effect on other variants of concern are ongoing.

Given the results of both the in vivo and in vitro studies, OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray warrant further investigation as an antiviral agent for pre-exposure prophylaxis, post-exposure prophylaxis, and/or prevention of transmission of SARS-CoV-2. Additional in vivo and in vitro studies are ongoing.

OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray have not been proven safe or effective to prevent SARS-CoV-2 infection or treat COVID-19 in humans nor has OC-01 (varenicline) or OC-02 (simpinicline) nasal spray been approved for any use by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for OC-01 (varenicline) nasal spray is October 17, 2021, with a planned U.S. launch in the fourth quarter of 2021, if approved by the FDA.

Oyster Point Pharma plans to present additional data at the upcoming Oyster Point Analyst Day, planned for July 15, 2021. Please use the following link to register for the Analyst Day (https://media.rampard.com/20210715/).

About Oyster Point Pharma

Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical and biologic therapies to treat ophthalmic diseases.

About the Trudeau Institute

The Trudeau Institute, headquartered in Saranac Lake, N.Y., safeguards human health by combatting 21st-century global health crises, such as the rise of drug-resistant tuberculosis, COVID-19 and emerging pandemic viruses. Its roots can be traced to 1884, when Edward Livingston Trudeau launched the first American laboratory solely dedicated to tuberculosis research. Today, Trudeau scientists spearhead innovation by conducting urgent biomedical research on infectious disease and collaborating with national and international R&D partners to accelerate medical impact.

About OC-01 (varenicline) Nasal Spray

OC-01 (varenicline) nasal spray is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. Varenicline tartrate is a partial nicotinic acetylcholine receptor agonist of α4β2 and α4α6β2 receptors, a moderate α3β4 and α3α5β4 receptor agonist, and a full α7 receptor agonist. Varenicline has been hypothesized to form a complex with an epitope of the Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2) spike protein that may block binding to receptors important for cellular entry, resulting in the prevention of viral entry into tissues1. The administration of a nasal spray formulation of varenicline provides a high localized dose directly to the nasal mucosa, a frequent site of virus entry, replication and infection. Varenicline has been shown to inhibit viral entry and disrupt replication of SARS-CoV-2-alpha in an in vivo model and has been shown to have potent antiviral activity to SARS-CoV-2, SARS-CoV-2-alpha, and SARS-CoV-2-beta in in vitro assays. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in this indication in the fourth quarter of 2021, if approved by the FDA. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not been established.

About OC-02 (simpinicline) Nasal Spray

OC-02 (simpinicline) nasal spray is a highly selective cholinergic agonist. Simipinicline citrate is a strong nicotinic acetylcholine receptor agonist of activity at the α4β2, α3β4, α3α5β4, and α4α6β2 receptors and weak agonist activity at the α7 receptor. OC-02 has been previously studied in two Phase 2b clinical trials for dry eye disease.

About the SARS-CoV-2 Virus

The Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2) is the virus responsible for coronavirus disease 2019 (COVID-19). This virus is from the Coronaviridae family that are broadly distributed among humans, other mammals, and birds. SARS-CoV-2 is a positive-sense single-stranded RNA virus.  

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current beliefs, expectations and assumptions of the Company regarding the future of the Company’s business, our future plans and strategies, regulatory approvals, clinical results, future financial condition and other future conditions. All statements other than statements of historical facts contained in this press release, including express or implied statements regarding product candidates, regulatory approvals, planned preclinical studies and clinical trials, expected results of preclinical or clinical trials, and their timing and likelihood of success, expected research and development costs, as well as plans and objectives of management for future operations, are forward-looking statements. The words “if approved,” “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the timing or likelihood of regulatory filings and approvals for OC-01; the beneficial characteristics, safety, efficacy and therapeutic effects of OC-01; our plans relating to the further development and manufacturing of OC-01, including potential additional indications or disease areas to be evaluated and pursued; the timing of initiation of our future clinical trials; the uncertainties inherent in pharmaceutical research and development, including preclinical study and clinical trial results and additional analysis of existing data; the likelihood of our clinical trials demonstrating safety and efficacy of OC-01, and other positive results; our plans and potential for success relating to commercializing OC-01; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; our ability to recruit and retain key personnel needed to develop and commercialize our product candidates, if approved, and to grow our company; existing regulations and regulatory developments in the United States and other jurisdictions; our continued reliance on third parties to conduct additional preclinical studies and clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our financial performance; market conditions; the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements; and other risks described in the “Risk Factors” section included in our public filings that we have made and will make with the Securities and Exchange Commission (SEC). The Company is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

  1. Alexandris, N., Lagoumintzis, G., Chasapis, C. T., Leonidas, D. D., Papadopoulos, G. E., Tzartos, S. J., … & Farsalinos, K. (2021). Nicotinic cholinergic system and COVID-19: In silico evaluation of nicotinic acetylcholine receptor agonists as potential therapeutic interventions. Toxicology reports8, 73-83.
  2. Sungnak, W., Huang, N., Bécavin, C., Berg, M., Queen, R., Litvinukova, M., … & Barnes, J. L. (2020). SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells together with innate immune genes. Nature medicine, 26(5), 681-687.
  3. Gallo, O., Locatello, L. G., Mazzoni, A., Novelli, L., & Annunziato, F. (2020). The central role of the nasal microenvironment in the transmission, modulation, and clinical progression of SARS-CoV-2 infection. Mucosal immunology, 1-12.

Investor Contact: 
Tim McCarthy 
LifeSci Advisors, LLC 
(212) 915-2564 
[email protected]

Media Contact: 
Sheryl Seapy, Real Chemistry
(213) 262-9390
[email protected]

 



U.S. FDA Accepts Filing of HUTCHMED’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

– U.S. FDA has assigned a target action date of April 30, 2022 –

– If approved, surufatinib would be HUTCHMED’s first novel oncology drug marketed outside of China –

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., July 01, 2021 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration (“FDA”) has accepted its filing of the New Drug Application (“NDA”) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (“NETs”). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is April 30, 2022.

Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.

Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said: “This NDA filing acceptance of surufatinib in the U.S. is a significant achievement for HUTCHMED as we expand our global operations and work to bring our innovative oncology drugs to cancer patients worldwide. The FDA’s acceptance of the NDA highlights the clinical value of this submission package and the importance of bringing more treatment options to US NET patients.”

The NDA is supported by data from two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET‑p1 and SANET‑ep2 both previously reported in The Lancet Oncology), and a surufatinib study conducted in the U.S.3 The data package will also be used to file a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) imminently, based on scientific advice from the EMA’s Committee for Medicinal Products for Human Use.

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

About NETs

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET (“pNET”) or extra-pancreatic NET (“epNET”).

According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 143,000 estimated patients living with NET in the U.S. in 2020.4

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Surufatinib Development

NETs in the U.S. and Europe: In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019. A U.S. FDA NDA rolling submission was completed in April 2021, to be followed by a MAA submission to the EMA in Europe. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937).

epNETs in China: On December 30, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China (“NMPA”) for the treatment of epNET. Surufatinib is marketed in China under the brand name Sulanda®. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival (“PFS”) at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress and published in TheLancet Oncology in September 2020.5 Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

pNETs in China: On June 18, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNETs conducted in China. The pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at a preplanned interim analysis, leading to a second NDA accepted by the NMPA in September 2020. The positive results of this study were presented at the 2020 ESMO Virtual Congress and published simultaneously in The Lancet Oncology6, demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

Biliary tract cancer in China: In March 2019, HUTCHMED initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).

Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi® (toripalimab) and Tyvyt® (sintilimab), which are approved as monotherapies in China.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) (formerly Hutchison China MediTech) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the submission of an NDA for surufatinib for the treatment of NET with the FDA and the timing of such submission, the therapeutic potential of surufatinib for the treatment of patients with NET, the further clinical development of surufatinib in this and other indications and HUTCHMED’s expansion of its global operations. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of surufatinib for the treatment of patients with NET in the U.S., China and other jurisdictions such as the E.U., its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi

®

, and Tyvyt

®

as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and the Stock Exchange of Hong Kong. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries  
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
   
Media Enquiries  
Americas – Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
[email protected]
Europe – Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
[email protected]
Asia – Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile) / +852 9783 6894 (Mobile)
[email protected]
   
Nominated Advisor  
Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited +44 (20) 7886 2500

___________________________
1

Surufatinib in advanced neuroendocrine tumors – pancreatic.
2Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic).
3 ASCO 2021 J Clin Oncol 39, 2021 (suppl 15; abstr 4114)
4 According to Frost & Sullivan, in 2020, there were 19,000 newly diagnosed cases of NETs in the U.S. and an estimated 143,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.
5 Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4.
6 Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.



Armada Hoffler Properties to Discuss Second Quarter Earnings on August 3rd

VIRGINIA BEACH, Va., July 01, 2021 (GLOBE NEWSWIRE) — Armada Hoffler Properties, Inc. (NYSE: AHH) will report its earnings for the quarter ended June 30, 2021 at approximately 6:00 a.m. Eastern on Tuesday, August 3, 2021. At 8:30 a.m. Eastern on the same day, senior management will host a conference call and webcast to discuss earnings and other information.

To listen to the call, dial 877-407-3982 (domestic) or 201-493-6780 (international) approximately 10 minutes prior to the start time of the call. The conference call will also be available through the investors page of the Company’s website, ArmadaHoffler.com.

A telephonic replay will be available shortly after the conclusion of the call through Friday, September 3, 2021. This replay may be accessed by dialing 844-512-2921 (domestic) or 412-317-6671 (international) and providing passcode 13720484. A replay of the webcast will also be available for 30 days beginning approximately two hours after the conclusion of the conference call.

About Armada Hoffler Properties, Inc.

Armada Hoffler Properties (NYSE: AHH) is a vertically-integrated, self-managed real estate investment trust with four decades of experience developing, building, acquiring and managing high-quality office, retail and multifamily properties located primarily in the Mid-Atlantic and Southeastern United States. The Company also provides general construction and development services to third-party clients, in addition to developing and building properties to be placed in their stabilized portfolio. Founded in 1979 by Daniel A. Hoffler, Armada Hoffler has elected to be taxed as a REIT for U.S. federal income tax purposes. For more information visit ArmadaHoffler.com.

Contact:

Michael P. O’Hara
Armada Hoffler Properties, Inc.
Chief Financial Officer, Treasurer, and Secretary
Email: [email protected]
Phone: (757) 366-6684



NewAge, Inc., Honored by Hermes Awards for Its Direct-to-Consumer and Social Media Marketing

Five-time award winner for excellence in the social media, social campaigns and advertising, and its development of the NewAge Share™ app

DENVER, July 01, 2021 (GLOBE NEWSWIRE) — NewAge, Inc. (Nasdaq: NBEV), the Colorado-based organic and healthy products company intending to become the world’s leading social selling and distribution company, today announced that NewAge, Inc. has been honored as a five-time award winner in both direct-to-consumer marketing and corporate image categories in the Hermes Creative Awards Competition.

Hermes Creative Awards is an international competition for creative professionals involved in the concept, writing and design of traditional and emerging media. Hermes Creative Awards recognizes outstanding work in the industry while promoting the philanthropic nature of marketing and communication professionals. Administered by the Association of Marketing and Communication Professionals (AMCP), the international organization consists of several thousand marketing, communication, advertising, public relations, digital media production and freelance professionals. AMCP oversees awards and recognition programs, provides judges and awards for outstanding achievement and service to the profession. Judges are industry professionals who look for companies and individuals whose talent exceeds a high standard of excellence and whose work serves as a benchmark for the industry.

NewAge, Inc. was awarded the highest honors for its creative social media campaign and design work in Interactive Social Media for its Icon Social Series and also won in the Interactive Media category for its NewAge Share App.

In the Interactive Social Media Campaign category, New Age’s Lucim™ brand was honored for its Mother’s Day Social Series. NewAge also won awards for its Lucim Sunscreen Social Series that it launched in China earlier this year, and its Lucim Skincare Social Series. The Lucim brand continues to gain notoriety, was recently highlighted in Italian Vogue, and was also recognized by the Good Face Project as being some of the highest quality, clean, non-toxic skincare available worldwide.

More than 6,000 entries were received for the Hermes Creative Awards 2021 competition, with NewAge being one of leading award recipients recognized with 5 awards. Karima McDaniel, VP of Marketing at NewAge commented, “Our direct/social selling business experienced a year-over-year sales increase of 128% last year. We continue to lead the evolution of Direct-to-Consumer (D2C) industry with leading tools, content, and technology for our more than 400,000 brand partners and customers across more than 50 countries. This achievement highlights our dedication to leading the industry and the social selling revolution by providing award-winning content for our Brand Partners and consumers. We are honored to be recognized by the Hermes Creative Awards and believe we are well on our way to achieving our vision of becoming the world’s leading social selling and distribution company.”

About Hermes Creative Awards

Hermes Creative Awards is administered and judged by the Association of Marketing and Communication Professionals www.hermesawards.com. The AMCP have coordinated and judged the awards for more than 20 years. Entrants contend for Platinum and Gold statuettes – wings from the mythological Hermes’ cap and sandals, elegantly etched to evoke the shape of the letter H.

About NewAge, Inc.
NewAge is a purpose-driven firm intending to become the world’s leading social selling and distribution company. Colorado-based NewAge commercializes a portfolio of organic and healthy products worldwide through primarily a direct route-to-market system. The company competes in three major category platforms including health and wellness, inner and outer beauty, and nutritional performance and weight management — leading a network of more than 400,000 exclusive independent distributors and Brand Partners around the world.

The company operates the websites NewAge.com, NoniNewAge.com, ARIIX.com, MaVie.com, TheLIMUCompany.com and Zennoa.com websites.  

Safe Harbor Disclosure

This press release contains forward-looking statements that are made under the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statement reflecting management’s expectations regarding future results of operations, economic performance, and financial condition. The forward-looking statements are based on the assumption that operating performance and results will continue in line with historical results. Management believes these assumptions to be reasonable, but there is no assurance they will prove to be accurate. Forward-looking statements, specifically those concerning future performance, are subject to certain risks and uncertainties, and actual results may differ materially. NewAge competes in a rapidly growing and transforming industry, and risk factors, including those disclosed in the Company’s filings with the Securities and Exchange Commission, might affect the Company’s operations. Unless required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements.

For investor inquiries about NewAge please contact:

NewAge Investor & Public Relations:

Mindy Eardley
Director, Public and Investor Relations
Tel: 1-801-573-4818
[email protected]

NewAge Investor Relations

BPC Financial Marketing
800 816 7361
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9b840bd5-134e-476b-af20-98155f7fa8d8



Arcutis Provides Update on Phase 2a Clinical Trial Evaluating ARQ-252 Cream as a Potential Treatment for Vitiligo

  • Formulation-related observations from ARQ-252 trial in chronic hand eczema informed early termination of Phase 2a ARQ-252 trial in vitiligo
  • Company progressing new formulation with goal of greater drug delivery to targets in the skin

WESTLAKE VILLAGE, Calif., July 01, 2021 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), today announced its decision to terminate the recently initiated Phase 2a clinical trial evaluating ARQ-252, a topical small molecule inhibitor of Janus kinase type 1 (JAK1), as a potential treatment for vitiligo (ARQ-252-213). Arcutis’ decision is based on further analyses of the ARQ-252 drug formulation used in both this vitiligo study and the recently completed Phase 2b study evaluating ARQ-252 for the treatment of chronic hand eczema (ARQ-252-205).

As previously announced, the Phase 2b chronic hand eczema study did not meet its primary endpoint, with none of the ARQ-252 arms achieving statistical significance versus vehicle. Further analyses of that study pointed toward inadequate local drug delivery to the skin as a key driver of the lack of efficacy.

“While we are disappointed to terminate this vitiligo study, we believe topical JAK inhibition remains a promising strategy for the treatment of both chronic hand eczema and vitiligo, and that ARQ-252 has potential as a new treatment for both diseases. Published clinical data for other topical JAK inhibitors have shown encouraging results in both indications. Furthermore, the active pharmaceutical ingredient in ARQ-252 — SHR0302 — is a potent and highly selective JAK1 inhibitor that has demonstrated efficacy and safety as an investigational oral formulation in other inflammatory conditions such as rheumatoid arthritis and atopic dermatitis,” said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. “We have already made good progress in reformulating ARQ-252 to potentially deliver much more active drug to targets in the skin and hope to re-enter the clinic with this reformulated version in the not-too-distant future. We want to thank the patients and investigators in the vitiligo study for their participation.”

The vitiligo study is not being terminated for any safety or tolerability reasons. ARQ-252 has been safe and well-tolerated, and no unexpected safety concerns have been identified.

About ARQ-252

ARQ-252 is a small molecule inhibitor of Janus kinase type 1 (JAK1). Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function. Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, Crohn’s disease, and atopic dermatitis. The Company believes that due to its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to effectively treat inflammatory diseases without causing the hematopoietic adverse effects typically associated with JAK2 inhibition. In 2018, Arcutis exclusively licensed the active pharmaceutical ingredient in ARQ-252 for all topical dermatological uses in the United States, Europe, Japan and Canada from Jiangsu Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed a Phase 2b study in rheumatoid arthritis that used the same active pharmaceutical ingredient as in ARQ-252 but dosed orally. The results confirmed that this active pharmaceutical ingredient is a highly potent inhibitor of JAK1 based on the drug’s impact on rheumatoid arthritis, and was generally well tolerated at exposures well above those expected with topical administration of ARQ-252 in patients with chronic hand eczema. In 2020, Reistone Biopharma, a subsidiary of Hengrui, announced positive topline results from a Phase 2 clinical trial evaluating the oral version of the active ingredient in ARQ-252 for the treatment of moderate-to-severe atopic dermatitis. Reistone Biopharma is also studying the oral formulation as a potential treatment for alopecia areata, Crohn’s disease, and ulcerative colitis.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with seven clinical programs for a range of inflammatory dermatological conditions, with our first NDA submission by the end of 2021 and three more Phase 3 clinical data readouts anticipated over the next 18 months. The company’s lead product candidate, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn and Twitter.

Forward-Looking Statements
This press release contains “forward-looking” statements, including, among others, statements regarding the potential for Arcutis to conduct clinical trials with a reformulated ARQ-252 and for the reformulated product to treat chronic hand eczema and vitiligo. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investor and Media Contact:


[email protected]





Pizza Hut Releases Limited Edition Hawaiian Pizza Shirts

Canada NewsWire

Pineapple-on-pizza fans can now proudly wear their pizza choice in style


TORONTO
, July 1, 2021 /CNW/ – Today Pizza Hut launches an exclusive, limited-edition Hawaiian Pizza Shirt to celebrate the most controversial pizza topping of all-time: pineapple. With new research showing thirty per cent of Canadians feel that pineapple should never be on a pizza, Pizza Hut is offering Hawaiian pizza lovers an opportunity to announce their love for pineapple to the world by wearing it with style.

The Hawaiian Pizza Shirts are inspired by the classic Hawaiian shirts of the 80s and 90s, with a delicious refresh that Hawaiian Pizza fans will go ham for. The Pizza Wear features design elements like a pizza-shaped pocket, blooming pizza slices and a pineapple island. Pineapple pizza lovers take a lot of heat for their preferences, but now fans don’t have to live in hiding anymore, they can unabashedly show their Hawaiian Pizza love, and look good doing it.

“We know that almost one in five Canadians believe Hawaiian pizza originated in Hawaii, when in fact it was developed in Ontario. We wanted to celebrate the origins of this polarizing dish the only way we know how: with more pizza,” says Amy Rozinksy, Head of Consumer Marketing, Pizza Hut Canada. “We are so excited to launch this limited edition Pizza Wear to pineapple-on-pizza fans everywhere.”

Research also found that some Canadians are so anti-pineapple, they’d take just about anything on their pizza instead, including:

  • Mashed potatoes
  • Ketchup
  • Brussel sprouts
  • Eggs

Interestingly, many Canadians feel so strongly about pineapple preference, they’d stake their love life on it. Research shows that 9% of Canadians could never select a partner that has a different opinion regarding pineapple on pizza.

Pizza Hut is in it for the love of pizza and are proud to be pizza recipe-neutral. The Hawaiian Pizza Shirt is there for Canadians to proudly wear their love of pizza. For a chance to secure your very own Hawaiian Pizza Shirt, visit Pizza Hut Canada’s Instagram page @PizzaHutCanada.

About Pizza Hut Canada

Pizza Hut is proud to be one of Canada’s largest pizza restaurant chains with over 450 locations locally. Globally Pizza Hut is the world’s largest pizza restaurant company with more than 18,000 restaurants in over 100 countries. No matter where you find a Pizza Hut, they are making sure each meal customers enjoy is safe, delicious, and delivers that satisfying taste of Pizza Hut.

Pizza Hut, Inc. is a subsidiary of Yum! Brands, Inc. (NYSE: YUM). Hungry for more information? Check out www.pizzahut.ca, www.facebook.com/PizzaHutCanada, www.twitter.com/pizzahutcanada and/or www.instagram.com/pizzahutcanada.

SOURCE Pizza Hut Canada

Aurora Mobile Partners with Leading Land Freight Logistics Platform Haoyunbao APP to Empower Smart Trucking Experience

SHENZHEN, China, July 01, 2021 (GLOBE NEWSWIRE) — Aurora Mobile Limited (NASDAQ: JG) (“Aurora Mobile” or the “Company”), a leading mobile developer service provider in China, today announced that it has entered into a partnership agreement with Hefei Weitian Yuntong Information Technology Co. Ltd. (“Hefei Weitian”), a leading logistics information service provider. Aurora Mobile will help Hefei Weitian by providing Video-as-a-Service solutions (“JG VaaS”) to boost user acquisition and engagement for its trucking logistics APP – Haoyunbao.

In China, about 80% of the trucking logistics industry is undertaken by independent truckers. They face a number of challenges such as insecure job environment, low shipping rates, long distance solo driving, limited access to emergency services and road rescue services. Designed to tackle these issues, the Haoyunbao APP lists shipping orders and enables secure shipping payments, in addition to on-demand entertainment videos and provides trucking assistance and other useful information to drivers.

JG VaaS brings on-demand short entertainment videos to Haoyunbao users

The trucking logistics industry is typically characterized as solo truck driving over long distances. Long-haul truckers usually drive alone for a significant amount of time, so watching short videos has become their main source of recreation when they stop for breaks. Before the adoption of JG VaaS, Haoyunbao’s in-house team used to collect and upload videos for its users. However, this approach was inefficient as limited videos were available and required extensive manpower and resources. Other methods deployed also did not allow Haoyunbao to attain a library of diversified video content at reasonable costs.

The launch of JG VaaS has effectively addressed these pain points. Currently, JG VaaS has over 100,000 contracted content creators producing over 130 million high-quality short videos, and more than 200,000 daily updates. APPs like Haoyunbao, which was already equipped with video service capabilities but lacked high-quality video content, can easily connect to the JG VaaS API to access the huge amount of high-quality video resources. APPs without short video features can also allow users to watch videos on horizontal or vertical screens by installing JG VaaS SDK.

By leveraging the advanced analytical capabilities that Aurora Mobile has accumulated for almost a decade, JG VaaS provides Haoyunbao users with enriched video content and more personalized video recommendations. Aurora Mobile has a proven architecture that can host tens of billions of daily visitors, and continues to guarantee service stability throughout the network at all times. Powered by JG VaaS, Haoyunbao APP can easily access short video services without the need for additional in-house operations, and feature high-quality short video content that are comparable to that of Douyin or Kuaishou.

JG VaaS focuses on users’ needs and empowers value creation for higher customer retention

Mr. Meng Yan, the product head of Haoyunbao commented, “Even before introducing JG VaaS, we have been a long-time customer of Aurora Mobile. We have always been very satisfied with their products and services, especially JPush, its push notification services. JG VaaS has increased our user retention time and met our needs for short entertainment videos, and its dedicated one-on-one customer service has impressed us beyond expectations.”

Mr. Shan Jie, Aurora Mobile’s head of JG VaaS business commented, “The cooperation with Haoyunbao demonstrates the industry-wide acclaim and trust that Aurora Mobile commands for our robust technical capabilities and services we provide to leading land freight logistics platforms in China. Going forward, we will work together to enhance the operations of Haoyunbao’s short video ecosystem. Meanwhile, Aurora Mobile continues to leverage our extensive experience with developer services to help developers optimize user experience, improve user stickiness and increase users’ average daily screen time.”

Aurora Mobile is a leading mobile development service provider in China. For almost a decade, Aurora Mobile has focused on meeting the needs of developers and has launched a series of products to help them to improve operational efficiency, drive business growth and monetize services. As of March 2021, Aurora Mobile provided software development kits to over 1.73 million APPs. The Company also launched a Unification Messages System (“JG UMS”) recently, which has integrated seven major messaging channels namely mobile Apps, WeChat official accounts, WeChat mini-programs, Short Message Service (“SMS”), emails, Fuwu Alipay and DingTalk, and enables enterprise users to reach their target customers more efficiently through one integrated messaging platform.

About Aurora Mobile Limited

Founded in 2011, Aurora Mobile is a leading mobile developer service provider in China. Aurora Mobile is committed to providing efficient and stable push notification, one-click verification, and APP traffic monetization services to help developers improve operational efficiency, grow and monetize. Meanwhile, Aurora Mobile’s vertical applications have expanded to market intelligence, financial risk management, and location-based intelligence, empowering various industries to improve productivity and optimize decision-making.

For more information, please visit http://ir.jiguang.cn/

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Among other things, the Business Outlook and quotations from management in this announcement, as well as Aurora Mobile’s strategic and operational plans, contain forward-looking statements. Aurora Mobile may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including but not limited to statements about Aurora Mobile’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: Aurora Mobile’s strategies; Aurora Mobile’s future business development, financial condition and results of operations; Aurora Mobile’s ability to attract and retain customers; its ability to develop and effectively market data solutions, and penetrate the existing market for developer services; its ability to transition to the new advertising-driven SaaS-model; its ability maintain or enhance its brand; the competition with current or future competitors; its ability to continue to gain access to mobile data in the future; the laws and regulations relating to data privacy and protection; general economic and business conditions globally and in China and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks is included in the Company’s filings with the Securities and Exchange Commission. All information provided in this press release and in the attachments is as of the date of the press release, and Aurora Mobile undertakes no duty to update such information, except as required under applicable law.

For general inquiry, please contact:

Aurora Mobile Limited

E-mail: [email protected]

Christensen
In China
Mr. Eric Yuan
Phone: +86-10-5900-1548
E-mail: [email protected]

In US
Ms. Linda Bergkamp
Phone: +1-480-614-3004
Email: [email protected]



XPeng Announces Vehicle Delivery Results for June and Second Quarter 2021

XPeng Announces Vehicle Delivery Results for June and Second Quarter 2021

  • 6,565 vehicles delivered in June 2021, a record month with a 617% increase year-over-year
  • 17,398 vehicles delivered in 2Q 2021, a record quarter with a 439% increase year-over-year
  • 4,730 P7s delivered in June 2021, the highest monthly deliveries since the P7’s launch
  • 30,738 total vehicles delivered year-to-date, a 459% increase year-over-year

GUANGZHOU, China–(BUSINESS WIRE)–
XPeng Inc. (“XPeng” or the “Company,” NYSE: XPEV, HKEX: 9868.HK), a leading Chinese smart electric vehicle (“Smart EV”) company, today announced its vehicle delivery results for June 2021 and the second quarter 2021.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210701005336/en/

The XPeng P7 Wing (Photo: Business Wire)

The XPeng P7 Wing (Photo: Business Wire)

XPeng recorded its highest-ever monthly deliveries in June of 6,565Smart EVs, representing a 617% increase year-over-year, and a 15% increase over last month. The Company also achieved a quarterly record of 17,398 deliveries in the second quarter 2021, marking a 439% increase year-over-year.

June deliveries consisted of 4,730 P7s, the Company’s sports smart sedan, and 1,835 G3s, its smart compact SUV. As of June 30, 2021, year-to-date total deliveries reached 30,738 units, representing a 459% increase year-over-year.

P7 deliveries continued record-breaking growth in June, reflecting the P7’s rising popularity among China’s tech-savvy consumers. Since mid-2020, 34,588 P7s have been delivered. The P7’s Navigation Guided Pilot (NGP) highway solutions are attracting wide customer appeal, reinforcing the Company’s commitment to technology innovation.

The Company plans to launch the G3i SUV, the new mid-phase facelift version of G3, in July 2021, with deliveries planned for September this year. XPeng also plans to launch its third production model, the P5 family-friendly smart sedan, in the third quarter 2021 with deliveries expected in the fourth quarter 2021. Upon delivery, the P5 will be the world’s first mass-produced Smart EV equipped with auto-grade LiDAR technology.

About XPeng Inc.

XPeng is a leading Chinese smart electric vehicle company that designs, develops, manufactures, and markets Smart EVs that appeal to the large and growing base of technology-savvy middle-class consumers in China. Its mission is to drive Smart EV transformation with technology and data, shaping the mobility experience of the future. In order to optimize its customers’ mobility experience, XPeng develops in-house its full-stack autonomous driving technology and in-car intelligent operating system, as well as core vehicle systems including powertrain and the electrification/electronic architecture. XPeng is headquartered in Guangzhou, China, with offices in Beijing, Shanghai, Silicon Valley and San Diego. The Company’s Smart EVs are manufactured at plants in Zhaoqing and Zhengzhou, located in Guangdong and Henan provinces, respectively. For more information, please visit https://en.xiaopeng.com.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Statements that are not historical facts, including statements about XPeng’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: XPeng’s goals and strategies; XPeng’s expansion plans; XPeng’s future business development, financial condition and results of operations; the trends in, and size of, China’s EV market; XPeng’s expectations regarding demand for, and market acceptance of, its products and services; XPeng’s expectations regarding its relationships with customers, contract manufacturers, suppliers, third-party service providers, strategic partners and other stakeholders; general economic and business conditions; and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks is included in XPeng’s filings with the SEC. All information provided in this press release is as of the date of this press release, and XPeng does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

For Investor Enquiries:

IR Department

XPeng Inc.

Email: [email protected]

Jenny Cai

The Piacente Group

Tel: +1 212 481 2050 / +86 10 6508 0677

Email: [email protected]

For Media Enquiries:

Marie Cheung

XPeng Inc.

Tel: +852 9750 5170 / +86 1550 7577 546

Email: [email protected]

Media Relations

For further information, please contact:

Wonderful Sky Financial Group Ltd.

Angie Li / Jerry Lou / Cici Zhu

Tel: +852 3970 2273 / +852 3970 2157 / +852 3977 1854

Email: [email protected] / [email protected] / [email protected]

KEYWORDS: China Asia Pacific

INDUSTRY KEYWORDS: General Automotive Automotive Alternative Vehicles/Fuels

MEDIA:

Photo
Photo
The XPeng P7 Wing (Photo: Business Wire)

Accenture to Acquire IT Services Provider Trivadis AG, Expanding Data and AI Capabilities to Help Companies Accelerate Data-Driven Transformation

Accenture to Acquire IT Services Provider Trivadis AG, Expanding Data and AI Capabilities to Help Companies Accelerate Data-Driven Transformation

GLATTBRUGG, Switzerland–(BUSINESS WIRE)–
Accenture (NYSE: ACN) has entered into an agreement to acquire Trivadis AG, an IT services provider specializing in platforms and solutions that enable highly automated provisioning and innovative use of data. Trivadis’s team of more than 710 professionals located across Switzerland, Germany, Austria, Denmark, and Romania will join Accenture’s Data & AI team within the Accenture Cloud First group. Financial terms of the acquisition were not disclosed.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210701005235/en/

Trivadis to become part of Accenture (Photo: Business Wire)

Trivadis to become part of Accenture (Photo: Business Wire)

With headquarters in Glattbrugg, Switzerland, Trivadis uses a suite of proprietary accelerators and assets to help companies advance their data platform lifecycles, automate operational tasks in databases, develop data warehouse solutions and accelerate cloud migrations. Trivadis works with clients to improve their data literacy, drive cloud-based data modernization journeys and deliver actionable insights. Trivadis also helps companies to refine business models and use new capabilities such as automation, AI and cloud services to lay a strategic foundation that draws the greatest possible value from data.

“Data’s worth depends on its accessibility and application. Cloud is the only place where data gains scale, agility and the power to drive reinvention so business can soar. Data is the vital source of business value today. However, the power of data can be limited if locked in legacy, on-premises platforms,” said Karthik Narain, global lead for Accenture Cloud First. “Acquiring Trivadis will strengthen our ability to help clients blend data from different sources together in real-time, build agile reporting, and leverage analytics and AI to create broadly accessible customer, market and operational insights that deliver meaningful business outcomes.”

“Data is fundamental for the development of any business today and has been part of Trivadis’s DNA since the beginning,” said Gerald Klump, co-CEO of Trivadis. “We are excited to join Accenture and to scale our value proposition to a larger client base.”

Ana Campos, co-CEO of Trivadis, added: “Together, we will create great opportunities for our people to develop and become the partner of choice for businesses to harness the power of data in the cloud.”

Frank Riemensperger, market unit lead for Accenture in Germany, Austria, Switzerland, and Russia, said: “Having Trivadis’s talented team join Accenture will strengthen our data on cloud capabilities with a strong focus on engineering. Combining these specific technological skills with Accenture’s business strategy expertise and global network, will scale our end-to-end data and analytics offering and reinforce Accenture’s cloud and data-driven reinvention strategies.”

Founded in 1994, Trivadis has worked with clients across industries including the public sector, automotive and life science industries. Trivadis has been recognized by the leading Swiss economic weekly Handelszeitung as a top employer in the category “Internet, Telecommunications and IT” for 2021.

Completion of the acquisition is subject to customary closing conditions.

About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Interactive, Technology and Operations services — all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 569,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities. Visit us at www.accenture.com.

Forward-Looking Statements

Except for the historical information and discussions contained herein, statements in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “should,” “likely,” “anticipates,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “positioned,” “outlook” and similar expressions are used to identify these forward-looking statements. These statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied. Many of the following risks, uncertainties and other factors identified below are, and will be, amplified by the COVID-19 pandemic. These risks include, without limitation, risks that: Accenture and Trivadis will not be able to close the transaction in the time period anticipated, or at all, which is dependent on the parties’ ability to satisfy certain closing conditions; the transaction might not achieve the anticipated benefits for Accenture; Accenture’s results of operations have been significantly adversely affected and could in the future be materially adversely impacted by the COVID-19 pandemic; Accenture’s results of operations have been, and may in the future be, adversely affected by volatile, negative or uncertain economic and political conditions and the effects of these conditions on the company’s clients’ businesses and levels of business activity; Accenture’s business depends on generating and maintaining ongoing, profitable client demand for the company’s services and solutions including through the adaptation and expansion of its services and solutions in response to ongoing changes in technology and offerings, and a significant reduction in such demand or an inability to respond to the evolving technological environment could materially affect the company’s results of operations; if Accenture is unable to keep its supply of skills and resources in balance with client demand around the world and attract and retain professionals with strong leadership skills, the company’s business, the utilization rate of the company’s professionals and the company’s results of operations may be materially adversely affected; Accenture could face legal, reputational and financial risks if the company fails to protect client and/or company data from security incidents or cyberattacks; the markets in which Accenture operates are highly competitive, and Accenture might not be able to compete effectively; Accenture’s profitability could materially suffer if the company is unable to obtain favorable pricing for its services and solutions, if the company is unable to remain competitive, if its cost-management strategies are unsuccessful or if it experiences delivery inefficiencies or fail to satisfy certain agreed-upon targets or specific service levels; changes in Accenture’s level of taxes, as well as audits, investigations and tax proceedings, or changes in tax laws or in their interpretation or enforcement, could have a material adverse effect on the company’s effective tax rate, results of operations, cash flows and financial condition; Accenture’s ability to attract and retain business and employees may depend on its reputation in the marketplace; as a result of Accenture’s geographically diverse operations and its growth strategy to continue to expand in its key markets around the world, the company is more susceptible to certain risks; Accenture’s business could be materially adversely affected if the company incurs legal liability; Accenture’s work with government clients exposes the company to additional risks inherent in the government contracting environment; Accenture’s results of operations could be materially adversely affected by fluctuations in foreign currency exchange rates; if Accenture is unable to manage the organizational challenges associated with its size, the company might be unable to achieve its business objectives; if Accenture does not successfully manage and develop its relationships with key alliance partners or fails to anticipate and establish new alliances in new technologies, the company’s results of operations could be adversely affected; Accenture might not be successful at acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses; if Accenture is unable to protect or enforce its intellectual property rights or if Accenture’s services or solutions infringe upon the intellectual property rights of others or the company loses its ability to utilize the intellectual property of others, its business could be adversely affected; Accenture’s results of operations and share price could be adversely affected if it is unable to maintain effective internal controls; changes to accounting standards or in the estimates and assumptions Accenture makes in connection with the preparation of its consolidated financial statements could adversely affect its financial results; Accenture might be unable to access additional capital on favorable terms or at all and if the company raises equity capital, it may dilute its shareholders’ ownership interest in the company; Accenture may be subject to criticism and negative publicity related to its incorporation in Ireland; as well as the risks, uncertainties and other factors discussed under the “Risk Factors” heading in Accenture plc’s most recent Annual Report on Form 10-K and other documents filed with or furnished to the Securities and Exchange Commission. Statements in this news release speak only as of the date they were made, and Accenture undertakes no duty to update any forward-looking statements made in this news release or to conform such statements to actual results or changes in Accenture’s expectations.

Copyright © 2021 Accenture. All rights reserved. Accenture and its logo are registered trademarks of Accenture.

Diana Büchner

Accenture

+06173 94 69081

[email protected]

Julie Bennink

Accenture

+1 312 693 7301

[email protected]

KEYWORDS: New York Europe Switzerland United States North America

INDUSTRY KEYWORDS: Technology Mobile/Wireless Audio/Video Consulting Professional Services Telecommunications Software Networks Internet Hardware Data Management Security Consumer Electronics VoIP

MEDIA:

Photo
Photo
Trivadis to become part of Accenture (Photo: Business Wire)